BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 2651448 · Received July 11, 2012

    Report

    Report Number
    2023826-2012-00540
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Report Date
    June 13, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K940593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. (OTHER): THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND A PIECE OF THE LENS OPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE. EVALUATION CODES: CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED LENS, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). OTHER TEXT: CARTRIDGE NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED A +18.5 DIOPTER AQ2015A SILICONE ASPHERIC THREE PIECE LENS WAS INSERTED AND A PIECE OF LENS WAS NOTED TO BE MISSING. THE LENS WAS REMOVED AND REPLACED. THE REPORTER INDICATED THE CAUSE OF THE LENS DAMAGE MAY HAVE BEEN DUE TO THE AQ CARTRIDGE-FP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY AQ CARTRIDGE-FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT NUMBER UNK| LENS MODEL AQ2015A - SERIAL NUMBER (B)(4)